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COMPLETED Phase 3

A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG

NCT00402506 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo.

Interventions

  • DRUG (MC-1) Pyridoxal 5'-phosphate

Study Locations (2)

North Carolina

  • Duke Clinical Research Institute — Durham

Quebec

  • Montreal Heart Institute — Montreal

Trial Details

FieldValue
Enrollment Target 3,000 participants
Start Date 2006-11
Est. Completion 2007-09
Phase Phase 3

Sponsor

Medicure

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00402506

The ClinicalTrials.gov registry entry for NCT00402506 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medicure, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Myocardial Ischemia appearing as the primary indexed condition, and to 1 intervention — of which (MC-1) Pyridoxal 5'-phosphate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00402506 reports 2 study locations spanning 2 distinct geographic areas — top geographies include North Carolina, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00402506 about?

NCT00402506 is a clinical study titled "A Safety and Efficacy Study to Confirm the Cardioprotective Effects of MC-1 in Patients Undergoing High-Risk CABG". The purpose of this study is to determine the effect of MC-1 on the combined incidence of cardiovascular death and nonfatal myocardial infarction (MI) up to and including 30 days following coronary artery bypass graft (CABG) surgery compared with placebo.

What is the current status of trial NCT00402506?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,000 participants. The study started on 2006-11. Estimated completion is 2007-09.

What conditions does trial NCT00402506 study?

This clinical trial studies the following conditions: Myocardial Ischemia, Reperfusion Injury, Coronary Artery Bypass Graft Surgery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00402506?

The interventions under investigation include: (MC-1) Pyridoxal 5'-phosphate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00402506?

This trial is sponsored by Medicure, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00402506 being conducted?

This trial has 2 study locations across North Carolina, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial